Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Pin, Fixation, Smooth
510(k) Number K852561
Device Name PIN SET, BONEM, RUSH, 1 THRU 10 INCHES LONG
Applicant
The Huxley Instrument Corp.
215 Main St.
Penn Yan,  NY  14527
Applicant Contact REBECCA J SHAHZADA
Correspondent
The Huxley Instrument Corp.
215 Main St.
Penn Yan,  NY  14527
Correspondent Contact REBECCA J SHAHZADA
Regulation Number888.3040
Classification Product Code
HTY  
Date Received06/17/1985
Decision Date 06/28/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-